Deferasirox - Generic Drug Details

What are the generic sources for deferasirox and what is the scope of freedom to operate?

Deferasirox is the generic ingredient in four branded drugs marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aucta, Aurobindo Pharma, Cipla, MSN, Norvium Bioscience, Teva Pharms Usa, Novartis, Actavis Elizabeth, Alembic, Bionpharma, Glenmark Speclt, Sun Pharm, Torrent, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Jubilant Generics, Piramal, Stevens J, and Novartis Pharms Corp, and is included in thirty-eight NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Deferasirox has sixty-seven patent family members in forty-two countries.

There are twenty drug master file entries for deferasirox. Twenty-one suppliers are listed for this compound.

Summary for deferasirox

International Patents:	67
US Patents:	1
Tradenames:	4
Applicants:	23
NDAs:	38
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	101
Patent Applications:	3,052
Drug Prices:	Drug price trends for deferasirox
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for deferasirox
What excipients (inactive ingredients) are in deferasirox?	deferasirox excipients list
DailyMed Link:	deferasirox at DailyMed

See drug prices for deferasirox

Recent Clinical Trials for deferasirox

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	PHASE2
University of Michigan Rogel Cancer Center	PHASE2
National Institutes of Health (NIH)	PHASE2

See all deferasirox clinical trials

Pharmacology for deferasirox

Drug Class	Iron Chelator
Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inducers Iron Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for deferasirox

V03AC	Iron chelating agents
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for DEFERASIROX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JADENU	Tablets	deferasirox	180 mg	206910	1	2016-04-21
JADENU	Tablets	deferasirox	90 mg and 360 mg	206910	1	2015-10-19
EXJADE	Tablets for Suspension	deferasirox	125 mg, 250 mg, and 500 mg	021882	1	2011-10-28

US Patents and Regulatory Information for deferasirox

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	DEFERASIROX	deferasirox	TABLET;ORAL	214474-002	Oct 16, 2023	AB	RX	No	No
Alkem Labs Ltd	DEFERASIROX	deferasirox	TABLET;ORAL	210555-001	Mar 30, 2020	AB	RX	No	No
Teva Pharms Usa	DEFERASIROX	deferasirox	GRANULE;ORAL	214180-001	Nov 19, 2021	AB	RX	No	No

Expired US Patents for deferasirox

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-001	Mar 30, 2015	6,465,504
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-001	Nov 2, 2005	6,465,504
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-003	Nov 2, 2005	6,465,504

EU/EMA Drug Approvals for deferasirox

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Deferasirox Mylan	deferasirox	EMEA/H/C/005014Deferasirox Mylan is indicated forthe treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and olderthe treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (	Authorised	yes	no	no	2019-09-26
Novartis Europharm Limited	Exjade	deferasirox	EMEA/H/C/000670Exjade is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged six years and older.Exjade is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) aged two to five years;in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (< 7 ml/kg/month of packed red blood cells) aged two years and older;in patients with other anaemias aged two years and older.Exjade is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.	Authorised	no	no	no	2006-08-28
Accord Healthcare S.L.U.	Deferasirox Accord	deferasirox	EMEA/H/C/005156Deferasirox Accord is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.Deferasirox Accord is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (	Authorised	yes	no	no	2020-01-09

International Patents for deferasirox

Country	Patent Number	Title	Estimated Expiration
Taiwan	201838623	Oral formulations of DEFERASIROX
European Patent Office	3124018
European Patent Office	2964202

Supplementary Protection Certificates for deferasirox

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0914118	06C0049	France		PRODUCT NAME: DEFERASIROX OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/06/356/001 DU 20060828; REGISTRATION NO/DATE AT EEC: EU/1/06/356/001 DU 20060828
0914118	C00914118/01	Switzerland		PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
0914118	PA2007001,C0914118	Lithuania		PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006-08-28, EU/1/06/356/002 2006-08-28, EU/1/06/356/003 2006-08-28, EU/1/06/356/004 2006-08-28, EU/1/06/356/005 2006-08-28, EU/1/06/356/00 20060828

Market Dynamics and Financial Trajectory for Deferasirox: An In-Depth Analysis

Last updated: July 27, 2025

Introduction

Deferasirox, an oral iron chelator marketed primarily under the brand name Exjade and later as Jadenu by Novartis, has become a cornerstone in managing chronic iron overload conditions such as transfusion-dependent anemias. Its unique pharmacological profile meets a growing global demand driven by increasing prevalence of conditions like thalassemia, sickle cell disease, and myelodysplastic syndromes. This article provides a comprehensive analysis of deferasirox’s market dynamics and projected financial trajectory, offering insights for stakeholders from pharmaceutical companies to investors.

Market Overview

Therapeutic Demand and Growing Patient Population

Deferasirox addresses a critical unmet need in managing iron overload—a complication of frequent blood transfusions. The global burden of transfusion-dependent disorders is expanding due to aging populations and improved survival rates of congenital anemias. The World Health Organization estimates that thalassemia affects approximately 60,000 newborns annually, with substantial cases in Asia, the Middle East, and Mediterranean regions (WHO, 2022). The rising incidence correlates with increased demand for effective iron chelation therapies.

Regulatory Approvals and Market Penetration

Since its FDA approval in 2005, deferasirox has witnessed widespread adoption facilitated by regulatory clearances across major jurisdictions, including the European Union, Japan, and China. Its oral administration offers a preferable alternative to parenteral agents like deferoxamine, boosting compliance and expanding market share. Novartis's strategic marketing and the drug's inclusion in numerous clinical guidelines have further entrenched its position globally.

Market Competition

Deferasirox faces competition from alternative chelators such as deferoxamine and deferiprone. While deferoxamine requires parenteral administration, deferiprone offers an oral option but with safety considerations like agranulocytosis risk. Emerging therapies involving combination regimens and new chelators under development also influence market dynamics. Nonetheless, deferasirox's established efficacy, safety profile, and convenience sustain its market dominance.

Market Dynamics

Pricing Strategies and Reimbursement Policies

Pricing significantly influences deferasirox’s market trajectory. Novartis initially adopted premium pricing, supported by its efficacy and unique oral formulation. However, pressure from healthcare payers and generic competition in some markets prompted price adjustments. Reimbursement policies vary globally; developed markets like the US and Europe offer favorable coverage, while emerging markets face challenges due to budget constraints, impacting sales volumes.

Patent Status and Generic Entry

The drug’s patent life has been a critical factor. Deferasirox’s patent expiration in several jurisdictions has paved the way for generic manufacturers, leading to price erosion. Generic entry, observed notably in India and China, has increased accessibility but exerted downward pressure on revenue streams for originators. Novartis has responded by developing branded options like Jadenu and emphasizing novel formulations and combination therapies.

Innovation and Line Extensions

R&D investments focus on optimizing dosing convenience, reducing adverse events, and expanding indications. A notable development is the oral dispersible tablet formulation, enhancing ease of use. Additionally, research into new chelators or combination regimens aims to extend the lifecycle of deferasirox's market presence and mitigate generic competition.

Geographical Expansion and Market Penetration

Emerging markets such as China, India, and Southeast Asia represent significant growth opportunities, driven by increasing diagnosis rates and improved healthcare infrastructure. Regulatory pathways in these regions are often streamlined, facilitating faster market entry. Strategic partnerships and licensing agreements further accelerate geographic expansion.

Financial Trajectory

Revenue Trends and Forecasts

Deferasirox's revenues have remained relatively stable in mature markets owing to its entrenched position. However, patent expirations and competitive pressures have prompted a slowdown in growth rates. The global iron chelation therapy market was valued at approximately USD 1.2 billion in 2021 and is projected to grow at a CAGR of 4.5% through 2028, with deferasirox maintaining a substantial share (Grand View Research, 2022).

Projected revenue post-patent expiry varies; in developed markets, generic competition could dilute revenue by 20-30% within five years. Conversely, increased adoption in emerging markets may partially offset this decline, supporting a plateau or modest growth in overall sales.

Cost Structure and Profitability

Operational costs include R&D, manufacturing, marketing, and regulatory compliance. While R&D costs for new formulations or combinations are significant, established manufacturing yields economies of scale. Profit margins are expected to decrease marginally with generic competition but remain healthy due to brand loyalty and therapeutic efficacy.

Investment and Strategic Considerations

Investors should monitor pipeline developments involving new formulations and indications, as these could rejuvenate revenue streams. Companies employing lifecycle management strategies—such as patent extensions or value-added formulations—can sustain profitability. Financial analysis also indicates that strategic alliances and licensing negotiations in emerging markets are vital for future revenue enhancement.

Regulatory and Market Challenges

Regulatory hurdles, especially concerning safety profiles related to long-term iron chelation, influence market acceptance. The occurrence of adverse events like renal impairment necessitates vigilant post-marketing surveillance. Consequently, approval processes in markets with stringent safety requirements could delay market entry, impacting revenue flows.

Moreover, the emergence of alternative therapies and generic competition compels manufacturers to innovate or diversify their product portfolios. Challenges related to access, affordability, and healthcare infrastructure also shape the market landscape.

Future Outlook

Market Growth Drivers

• Increasing prevalence of transfusion-dependent disorders
• Regulatory acceptance of new formulations and indications
• Expanding access in developing economies
• Clinical evidence supporting combination therapies

Market Constraints

• Patent expirations leading to generic competition
• Safety concerns influencing prescribing patterns
• Pricing pressures from payers worldwide
• Emerging competitive therapies

Potential Growth Opportunities

• Development of pediatric formulations
• Expansion into non-transfusion-related iron overload indications
• Integration with personalized medicine approaches
• Strategic partnerships in emerging markets

Key Takeaways

• Deferasirox remains a leading iron chelation agent owing to its oral formulation, strong clinical profile, and global acceptance. However, patent expiry and burgeoning generic competition pose revenue risks, particularly in mature markets.
• Market growth is primarily driven by rising global prevalence of transfusion-dependent conditions and expanding access in emerging economies. Strategic focus on regional expansion and product innovation is paramount.
• Pricing and reimbursement policies significantly influence market penetration, with healthcare system negotiations playing a pivotal role. Manufacturers must adapt to regional economic landscapes.
• R&D for new formulations, combination therapies, and indications will be critical to prolonging the drug’s lifespan and maintaining profitability. Lifecycle management strategies are essential.
• Stakeholders should closely monitor regulatory environments, safety profiles, and emerging competitors to optimize investment decisions and market positioning.

FAQs

1. What factors most significantly impact deferasirox’s market share globally?
   Patent status, generic entry, safety profile, pricing strategies, and reimbursement policies predominantly influence its market share.

2. How does patent expiration affect deferasirox’s financial trajectory?
   Patent expiry lowers barriers for generic manufacturers, leading to price reductions and reduced revenue for originators, although emerging formulations and indications can mitigate this decline.

3. What are the primary clinical benefits of deferasirox over alternative chelators?
   Its oral administration enhances patient compliance, and clinical trials show comparable or superior efficacy in iron reduction, with a favorable safety profile in appropriate patient populations.

4. In which regions does deferasirox have the greatest growth potential?
   Emerging markets like China, India, and Southeast Asia offer significant growth opportunities due to increasing disease prevalence and expanding healthcare infrastructure.

5. What innovations are expected to shape deferasirox’s future market trajectory?
   Development of pediatric formulations, combination therapies, and expanded indications, along with strategic geographic partnerships, will be instrumental.

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Sources:

[1] World Health Organization. (2022). Thalassemia prevalence and epidemiology report.
[2] Grand View Research. (2022). Iron Chelation Therapy Market Analysis and Forecasts.
[3] Novartis Annual Report. (2021). Strategic updates on deferasirox and pipeline developments.
[4] U.S. Food and Drug Administration. (2005). Approval documentation for deferasirox.